Cleared Traditional

K022366 - CELSIUS CONTROL SYSTEM

K022366 is an FDA 510(k) clearance for CELSIUS CONTROL SYSTEM, manufactured by Innercool Therapies. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K022366 · Innercool Therapies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
189d
Days
Class 2
Risk

K022366 is an FDA 510(k) clearance for the CELSIUS CONTROL SYSTEM. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Innercool Therapies (San Diego,, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 189 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K022366

510(k) Number K022366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date January 27, 2003
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 149d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCX Device Classification - Class 2, Special Controls

Product Code NCX System, Hypothermia, Intravenous, Cooling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NCX System, Hypothermia, Intravenous, Cooling

All 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K022366.
CELSIUS CONTROL SYSTEM
K033623 · Innercool Therapies, Inc. · May 2004
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
K030421 · Alsius Corp. · Oct 2003
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
K014241 · Alsius Corp. · Aug 2003
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
K012512 · Radiant Medical · Jun 2002
K022366 · CELSIUS CONTROL SYSTEM
Download PDF FDA Summary Innercool Therapies